Tele-Cardiac Rehabilitation Program

Heart Diseases Clinical Trial

Official title: Comprehensive Remote Multidisciplinary Cardiac Rehabilitation Program for Patients Unable to Attend an Institution Based Program

Status Not yet recruiting

Clinical Trial Summary

Rehabilitation programs that take place in hospitals and rehabilitation centers and all over the world are a necessary stage for returning the patients after a cardiac event to a normal functioning. However, about 70% of patients do not apply for the hospital rehabilitation programs after the heart event that they experience. The objective of this study is to evaluate and develop a multi-stage home rehabilitation program for remote rehabilitation, based on advanced technological infrastructure and complementary clinical protocols. The study population will include about 264 clinically stable patients who are eligible for cardiac rehabilitation, but for various reasons cannot get to the rehabilitation centers.

Clinical Trial Description

Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise, dietary intervention, secondary prevention by pharmacotherapy, and psychological intervention. Despite proven benefits including reduction in mortality, hospitalizations and marked improvement in well-being and function state, the current model is restrictive and requires patients' arrival to the hospital twice a week at predetermined hours. Major limitations associated with lack of participation in an in-hospital based cardiac rehabilitation program in 20-40% of eligible patients include limited transportation, time and social/family restraints, and inconvenience. Furthermore, the limited space, even in the largest rehabilitation in Israel located at Sheba Medical Center, prohibits wider availability. Leading key opinions leaders have designated cardiac-telerehabilitation as the most viable solution for the above-mentioned limitations, and several clinical studies have demonstrated safety and efficacy of this approach, including a Cochrane review and a recent meta-analysis. Nevertheless, tele-cardiac rehabilitation is not guideline recommended yet, and prospective randomized trials are necessary to better evaluate its role.

Study will enroll patients who are eligible to participate in an in-hospital cardiac rehabilitation program but are unable to participate due to one of the above-mentioned limitations, in a structured exercise and secondary prevention program in their communities. Consenting patients will undergo a baseline cardiopulmonary exercise test (CPET) followed by randomization to usual care vs. multidisciplinary intervention as described.

In addition to monitored physical activity, patients will receive nutritional and psychological counseling. This is part of a multi-professional rehabilitation program accepted by the rehabilitation center.

The study will enroll and randomize 264subjects to usual care vs. comprehensive tele-cardiac rehabilitation (TCR) with disease management services and demonstrate a greater improvement in functional capacity (O2 consumption) and improved clinical outcomes (secondary endpoints) in the TCR group.

Concomitant medications and guidelines: As indicated by national guidelines. No limitations

Study Duration: 12-month intervention period. Primary endpoint (percent change in O2 consumption) will be assessed following 3 months of intervention. Clinical event adjudication (hospitalizations, emergency department visits) will be performed throughout a 12-month period from enrollment.

Study Design: The study is an open-labeled double arm randomized prospective multi-center study designed to assess the effects of tele-CR compared to usual care in subjects that are unable to attend institution based CR despite compelling indications to CR. The intervention will be evaluated against usual care by family physician and cardiologist. The multidisciplinary program will include elements of education, nutritional and psychological interventions, monitored personalized exercise and medication titration according to the relevant national guidelines. The present sample will facilitate an evaluation of the hypothesis that tele-rehabilitation will be associated with a significant improvement in functional capacity, as assessed by the gold standard of CPET. We also hypothesize that the comprehensive intervention will also reduce clinical events, including all-cause hospitalization and death.

All subjects will undergo a detailed evaluation by rehabilitation specialist, nurse case manager, trainers and exercise physiologists. Both research arms will receive a dedicated application with a built-in pedometer and the ability to answer questionnaires. ;

Related Conditions & MeSH terms

• Heart Diseases

• NCT number: NCT03584828
• Study type: Interventional
• Source: Sheba Medical Center
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Completion date: July 2020